Prospecto:Information for the Patient

Sapropterina Teva 100 mg Soluble Tablets EFG

sapropterina dihidrocloruro

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospect. See section 4.

1.What is Sapropterina Teva and what is it used for

2.What you need to knowbeforestarting totake Sapropterina Teva

3.How to take Sapropterina Teva

4.Possible adverse effects

5Storage of Sapropterina Teva

6.Contents of the package and additional information

This medication contains the active ingredient sapropterin, which is a synthetic copy of a substance found naturally in the body called tetrahydrobiopterin (BH4). BH4 is necessary in the body to convert an amino acid called phenylalanine into another amino acid called tyrosine.

Sapropterina Teva is used to treat hyperphenylalaninemia (HPA) or phenylketonuria (PKU) in patients of any age. HPA and PKU are caused by abnormally high levels of phenylalanine in the blood that can be harmful. Sapropterin reduces these levels in some patients who respond to BH4 and may help increase the amount of phenylalanine that can be included in the diet.

This medication is also used to treat a hereditary disease called tetrahydrobiopterin deficiency in patients of any age, in which the body cannot produce enough BH4. Because BH4 levels are very low, the body cannot use phenylalanine properly and levels of this amino acid increase, having harmful effects. By substituting the BH4 that the body cannot produce, Sapropterina Teva reduces the damaging excess of phenylalanine in the blood and increases tolerance to phenylalanine in the diet.

Do not take Sapropterina Teva

If you are allergic to sapropterin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sapropterina Teva, especially:

• If you are 65 years or older
• If you have kidney or liver problems
• If you are ill. It is recommended to consult with your doctor in case of illness since the levels of phenylalanine in the blood may increase
• If you have a predisposition to seizures

When receiving treatment with sapropterin, your doctor will perform blood tests to verify the content of phenylalanine and tyrosine and be able to decide to adjust the dose of sapropterin or the diet if necessary.

You must continue the dietary treatment according to your doctor's recommendations. Do not change your diet without informing your doctor. Even when taking sapropterin, if your blood phenylalanine levels are not well controlled, you may experience severe neurological problems. Your doctor must continue to monitor your blood phenylalanine levels frequently during treatment with sapropterin, to ensure that they are not too high or too low.to ensure that they are not too high or too low.

Other medications and Sapropterina Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular, you must inform your doctor if you are using:

• levodopa (to treat Parkinson's disease)
• medications for cancer treatment (e.g. methotrexate)
• medications for bacterial infection treatment (e.g. trimethoprim)
• medications that cause vasodilation (e.g. glyceryl trinitrate [GTN], isosorbide dinitrate [ISDN], sodium nitroprusside [SNP], molsidomine, minoxidil).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, your doctor will instruct you on how to properly control your phenylalanine levels. If they are not strictly controlled before pregnancy or when you become pregnant, it may be harmful to you and your baby. Your doctor will supervise the restriction of phenylalanine intake through diet before and during pregnancy.

If a strict diet does not sufficiently reduce the amount of phenylalanine in the blood, your doctor will consider whether you should take this medication.

You should not use this medication during breastfeeding.

Driving and operating machinery

Sapropterina Teva is not expected to affect your ability to drive and use machines.

Sapropterina Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Dose for PKU

The recommended initial dose of Sapropterina Teva in patients with PKU is 10 mg per kg of body weight. Take Sapropterina Teva once a day, with a meal to increase absorption, and at the same time every day, preferably in the morning. Your doctor may adjust the dose, generally between 5 and 20 mg daily per kg of weight, according to your condition.

Dose for BH4 deficiency

The recommended initial dose of Sapropterina Teva in patients with BH4 deficiency is 2 to 5 mg per kg of body weight. Take Sapropterina Teva with a meal to increase absorption. Divide the total daily dose into 2 or 3 doses administered throughout the day. Your doctor may adjust the dose up to 20 mg daily per kg of weight, according to your condition.

The following table is an example of how to calculate the appropriate dose

Administration form

For patients with PKU, the total daily dose is taken once a day and at the same time every day, preferably in the morning.

For patients with BH4 deficiency, the total daily dose is divided into 2 or 3 doses distributed throughout the day.

Use in all patients

Place the prescribed tablets in a glass or cup of water, exactly as described below, and stir until dissolved.

The tablets may take a few minutes to dissolve. To dissolve the tablets faster, you can crush them. You may observe small particles in the solution that will not affect the efficacy of the medication. Drink the prepared Sapropterina Teva solution with a meal within 15 or 20 minutes after preparation.

Do not ingest the desiccant capsule included in the bottle.

Use in patients with a body weight over 20 kg

Place the tablets in a glass or cup (120 to 240 ml) of water and stir until dissolved.

Use in children up to 20 kg of body weight

The dose is based on body weight, which will change as the child grows. Your doctor will inform you:

• the number of Sapropterina Teva tablets needed for a dose
• the amount of water needed to mix a dose of Sapropterina Teva
• the amount of solution to administer to the child for the prescribed dose

The child should drink the solution with a meal.

Administer the child the prescribed amount of solution within 15 or 20 minutes after dissolution. If you cannot administer the dose to the child within 15 or 20 minutes after dissolution of the tablets, you will have to prepare a new solution, as the unused solution should not be used once 20 minutes have passed.

Materials needed to prepare and administer the child's dose of Sapropterina Teva

• The number of Sapropterina Teva tablets needed for a dose
• A medication cup with graduation marks corresponding to 20, 40, 60, and 80 ml
• A glass or cup
• A spoon or a clean utensil to stir
• An oral syringe (graduated in 1 ml divisions; a 10 ml syringe for administering volumes ≤10 ml or a 20 ml syringe for administering volumes >10 ml)

Ask your doctor for the medication cup to dissolve the tablets and the oral syringe of 10 ml or 20 ml if you do not have these materials.

Steps for preparing and taking the dose:

• Place the prescribed tablets in the medication cup. Pour the indicated amount of water into the medication cup (e.g., your doctor told you to use 20 ml to dissolve a Sapropterina Teva tablet). Check that the amount of liquid aligns (at the graduation mark corresponding to the medication cup) with the amount indicated by your doctor. Stir with the spoon or clean utensil until the tablets dissolve.
• If your doctor told you to administer only a part of the solution, insert the tip of the oral syringe into the medication cup. Pull the plunger slowly back to extract the indicated amount.
• Transfer the solution to a glass or cup dosifier by pushing the plunger slowly until all the solution previously introduced into the oral syringe dosifier is inside (e.g., if your doctor told you to dissolve two Sapropterina Teva tablets in 40 ml of water and administer 30 ml to the child, you will have to use the oral syringe dosifier of 20 ml twice to extract the 30 ml (e.g., 20 ml + 10 ml) of solution and transfer it to a glass or cup for administration). Use an oral syringe of 10 ml for administering volumes ≤10 ml or an oral syringe of 20 ml for administering volumes >10 ml.
• If the baby is too small to drink from a glass or cup, you can administer the solution using the oral syringe. Extract the prescribed volume of prepared solution from the dosifier glass and insert the tip of the oral syringe into the baby's mouth. Point the tip of the oral syringe towards one cheek. Push the plunger slowly, releasing a small amount at a time, until administering all the solution contained in the oral syringe.
• Discard any remaining solution. Extract the plunger from the body of the oral syringe. Wash both parts of the oral syringe and the dosifier glass with warm water and let them air dry. When the oral syringe is dry, insert the plunger back into the body of the oral syringe. Store the oral syringe and the medication cup for the next use.

If you take more Sapropterina Teva than you should

If you take more Sapropterina Teva than prescribed, you may experience adverse effects that may include headaches and dizziness. If you take more Sapropterina Teva than prescribed, inform your doctor or pharmacist immediately.

If you think you have taken an overdose and are experiencing any of these symptoms, inform your doctor immediately. You can also call the Toxicology Information Service, Tel. 91 562 0420.

If you forget to take Sapropterina Teva

Do not take a double dose to compensate for the missed doses. Take the next dose at the usual time.

If you interrupt treatment with Sapropterina Teva

Do not interrupt treatment with Sapropterina Teva without previously discussing it with your doctor, as it may increase blood phenylalanine levels.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Few cases of allergic reactions (such as skin rashes and severe reactions) have been reported. Their frequency is unknown (the frequency cannot be estimated from the available data).

If you have inflamed, red, and intensely itchy areas (urticaria), nasal discharge, rapid or irregular pulse, tongue or throat inflammation, sneezing, hissing while breathing, severe respiratory difficulty, or dizziness, you may be experiencing a severe allergic reaction to the medication. If you experience these symptoms, consult your doctor immediately.

Very Frequent Adverse Effects(may affect more than 1 in 10 people)

Headache and nasal discharge.

Frequent Adverse Effects(may affect up to 1 in 10 people)

Sore throat, congestion or nasal blockage, cough, diarrhea, vomiting, stomach pain, low phenylalanine levels in blood tests, indigestion, and general discomfort (nausea) (see section 2: "Warnings and Precautions").

Unknown Adverse Effects(cannot be estimated from the available data)

Gastritis (inflammation of the stomach lining), esophagitis (inflammation of the esophagus lining).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.esBy reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25?. Store in the original packaging to protect it from light and moisture.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Sapropterina Teva

• The active ingredient is dihydrochloride of sapropterin. Each tablet contains 100 mg of dihydrochloride of sapropterin (equivalent to 77 mg of sapropterin).
• The other components are mannitol (E421), pregelatinized cornstarch, crospovidone (E1202), riboflavin (E101), ascorbic acid (E300), stearate of fumaric acid and sodium.

Appearance of the product and contents of the packaging

Sapropterina Teva 100 mg soluble tablets are round white to light yellow tablets, approximately 9.5 mm in diameter, marked with “L71” on one face and “T” on the opposite face.

They are presented in high-density polyethylene (HDPE) bottles with a child-resistant safety closure. Each bottle contains 30 or 120 tablets. The bottles are sealed with an aluminum foil seal. Each bottle contains a small plastic tube with a desiccant (silica gel).

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Teva Operations Poland Sp. Z.o.o

ul. Mogilska 80

31-546 Krakow

Poland

Last review date of this prospectus:March 2022

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)